Devices, Systems, and Methods of Use for Delivery of Materials in Combination with Intramedullary Devices

This application is a continuation of U.S. application Ser. No. 18/164,584, filed Feb. 4, 2023, which claims the priority to U.S. Provisional Application No. 63/267,590, filed Feb. 4, 2022, each of which is incorporated herein by reference in its entirety.

Various treatments of bone conditions may involve the use of implantable devices such as bone screws, rods, plates, and the like. For example, large bone fractures such as pelvic and hip fractures frequently require the use of implantable intramedullary devices such as rods and/or screws extending at least partially through or within an intramedullary channel within the bone. In some cases, surgical tools such as reamers are used to create such intramedullary channels prior to implantation of the intramedullary device.

Pelvic fractures involve particularly complex repair procedures, due in part to their curved, saddle-like shape. To repair a fractured pelvis, the surgeon must insert rods or screws across the fracture(s) to immobilize the bone fragments and allow them to grow back together. The straight, rigid rods and screws conventionally used for fracture repairs frequently are unsuited for the pelvis due to their inability to conform to the complex curvature of the bone, or to follow a curved intramedullary channel formed in bone.

There is a need for improved devices, systems, and methods for treating fractures in curved bones.

Some embodiments of an implantable intramedullary device according to the present technology includes a device body having a proximal portion and an elongate portion that can pass through an intramedullary pathway within the bone, the elongate portion having a first end coupled to the proximal portion and a second end opposite the first end. The proximal portion may have a connection portion configured for connecting to an inserter device for inserting the intramedullary device into an intramedullary channel in the bone. A distal portion may be coupled to, or integrally formed with, the second end of the elongate portion.

In some embodiments, the elongate portion is flexible or shapable into a curved shape so as to be capable of following a curved intramedullary pathway in the bone. In such embodiments, the elongate portion will be lockable into a rigid state so as to maintain a desired curved shape while implanted in the bone. Such embodiments may further include a locking mechanism which can be actuated in the proximal portion for locking the elongate portion in the rigid state. In some embodiments, the locking mechanism is configured to be coupled to an actuator of an inserter device which can be actuated to lock the elongate portion in the rigid state.

The intramedullary device may further include a delivery channel extending through at least one of the proximal portion and the elongate portion, an inlet port in the proximal portion in communication with the channel, and one or more exit ports along the axial length of the proximal portion, elongate portion, and/or distal tip configured for delivery of a viscous liquid material such as bone cement, therapeutic agents such as biologics, drugs, or other materials. Such materials may be delivered for therapeutic purposes such as inhibiting or treating infection, promoting bone growth, or treating other conditions, for filling gaps within the bone, or for attaching or adhering an intramedullary implant to bone or to a prosthetic device (e.g. joint replacement prosthesis or other implant), as well as other purposes.

Some embodiments of the intramedullary implant may further include a connector, valve, or other fitting on the proximal portion which is in fluid communication with the inlet port and configured for connection to a syringe, injector, catheter, or other fluid delivery apparatus for delivering the bone cement, biologics or other materials through the inlet port and into the delivery channel. In some embodiments, the delivery apparatus is capable of delivering a viscous liquid material such as bone cement at sufficiently high pressures to pass through the delivery channel and exit ports into the intramedullary space. In some embodiments the delivery apparatus is configured to deliver materials having a viscosity in the range of about 10-1000 cP, 10-200 cP, or 10-100 cP, at pressures of no more than about 200-300 psi.

In some embodiments, the fluid delivery apparatus may include a delivery tube or catheter which may be inserted through the inlet port into the delivery channel and advanced a desired distance through the proximal portion, elongate portion, and/or distal portion. In this way, the liquid material may be directed to a selected one or more exit ports along the length of the intramedullary device, or to a location distally of the intramedullary device, so as to target desired locations within the intramedullary space to which the liquid material may be delivered. In such embodiments, the fitting, inlet port, and/or delivery channel can be configured to slidingly receive such tube or catheter and provide a fluid tight seal therewith to inhibit leakage of the liquid material through the inlet port under high pressures.

The present technology further provides an intramedullary treatment system comprising an intramedullary device and a fluid delivery apparatus as described above. The intramedullary treatment system may further include a container of a liquid material such as bone cement, biologic, drug, or other material, the container being adapted for fluid connection to the delivery apparatus. The intramedullary treatment system may alternatively or additionally include containers or packages of one or more components in a liquid or dry form, which can be combined with other compounds, agents, or media by the user to create the desired liquid material at the time of treatment.

In further embodiments, the intramedullary treatment system may include an inserter device for inserting the intramedullary device in bone. The inserter device may include a mechanism for locking the intramedullary device in a rigid state after insertion. In some embodiments, the inserter device may be configured to be fluidly and/or mechanically coupled to the fluid delivery apparatus and may be configured to direct liquid material into the delivery channel of the intramedullary device. Alternatively, the inserter device may include an introduction channel to receive a tube, catheter, or other delivery component of the fluid delivery apparatus and directing such component and/or liquid material into the delivery channel.

A catheter embodiment for delivering bone cement or biologics through the intramedullary implant can include a polymer tube sized appropriately to the channel in the intramedullary implant. One end of the tube may have any one of a variety of connectors to couple to a syringe of bone cement or biologics. The other end may have an additional connector to couple to a mating connector on the intramedullary implant. Alternatively, the end of the catheter may be open to deliver material through the end at a desired location inside the intramedullary implant. Additionally, the catheter may contain radiopaque markers or external markings to indicate depth of placement of the catheter with respect to the intramedullary implant or patient tissue. Moreover, the catheter may contain a number of side-holes in various quantities or patterns to deliver bone cement or biologics at multiple locations along the inside of the intramedullary implant.

The present technology is directed towards implantable intramedullary devices, and systems and methods related thereto, which enable delivery of liquid materials into an intramedullary channel in a bone. Delivery of liquid materials into the intramedullary channel in conjunction with the intramedullary implant may enhance fixation of the implants or immobilization of the bones, promote bone growth, ward off infection, reduce pain, inhibit or treat diseases, as well as serve other therapeutic purposes. Conventional intramedullary devices do not have such capability, as access into the intramedullary channel is blocked by the device itself.

The devices and systems disclosed herein allow therapeutic and other materials to be delivered into an intramedullary space before an intramedullary device is implanted, or while the intramedullary device is implanted, in order to enhance treatment of fractures and other bone conditions. The intramedullary devices of the present technology may either be straight, rigid devices, or flexible devices configured to follow a curved intramedullary channel then fixed in a rigid state once in an implanted position in the bone. In some embodiments, the present technology is configured to deliver liquid materials having high viscosity, such as bone cement, along with less viscous materials, such as biologics and pharmacologic solutions.

“Implantable,” as used herein, refers to anything intended to be implanted, i.e. fixed to or within a patient's body and left behind for an extended period of time (e.g., in excess of a few days or weeks), and in many cases, permanently. At least in the case of intramedullary devices, “implantable” is further intended to mean devices which are implanted through an incision in the skin and are disposed at least partially in an intramedullary space within a bone, and the devices remain in the bone after the incision is closed, with the entire device remaining under the skin.

1 FIG.A 1 FIG.B 8 8 10 12 14 11 12 14 10 24 30 24 32 14 24 14 10 20 8 shows a deviceconfigured to be implanted in an intramedullary channel of a bone, according to several embodiments of the present technology. The devicecomprises an elongate bodyhaving a proximal portion, a distal portion, and an elongate portionpositioned between the proximal and distal portions,. The elongate bodycan comprise a sidewall defining a lumen(see) extending therethrough and including a plurality of exit portsin fluid communication with the lumen. An openingat the distal end of the distal portioncan also be in fluid communication with the lumen. The distal portionof the elongate bodycan further include a threaded regionfor securing the devicein the bone.

12 8 12 16 18 16 18 12 22 22 12 23 24 10 22 26 22 28 23 22 26 28 1 FIG.B The proximal portioncan be configured to be coupled to an inserter device for inserting the deviceinto an intramedullary channel in a bone. The proximal portioncan include, for example, a headhaving a driver receptacle. As shown in the axial cross-sectional view of the headin, in some embodiments the driver receptablecan have a cross-sectional shape comprising a star. Other shapes are possible, such as a square, circle, triangle, undefined shape, polygon, and many others. In some embodiments, the proximal portionis configured to be coupled to a fitting(e.g., via a luer lock or other sealable connection methods). The fittingcan be configured to fluidly seal with the proximal portionand includes an inner passagethat communicates with the lumenwithin the elongate body. The fittinghas a proximal end portionconfigured to be coupled with a fluid delivery apparatus (not shown). Alternatively or additionally, the fittingmay have a sidearmhaving an inner lumen (not shown) communicating with the inner passageof the fitting. Either or both proximal end portionand sidearmmay have a coupling (e.g., a luer lock or other sealable connection method) for coupling to a fluid delivery tube or apparatus.

8 10 10 The devicecan be constructed of a biocompatible rigid material suitable for implantation in bone, such as stainless steel or titanium. The elongate bodycan have sufficient strength and bending stiffness as required for repair of bone fractures including, e.g., fractures of the pelvis, femur, tibia, humorous, spine, and other bones. The principles of the present technology may also be applied to other implantable devices for other purposes as well. The elongate bodycan have a length and diameter selected for the particular bone and nature of the treatment to be executed.

24 10 22 8 22 24 34 35 36 34 2 FIG.A The liquid material can be delivered into the lumenof the elongate bodydirectly through the fitting(when coupled to the device), or through an additional device configured to be received through the fittingand the lumen. For example, as shown in, the present technology can include a fluid delivery systemcomprising a fluid delivery deviceand a material source. The fluid delivery devicemay comprise, for example, a syringe, power injector, a pump, or other fluid delivery mechanism. The liquid material can comprise bone cement and/or a therapeutic agent (e.g., biologics, antibiotics, pharmacologic agents, or other materials useful in the relevant treatment).

8 24 30 35 28 22 36 23 22 24 10 34 38 22 23 28 35 26 22 38 Following insertion of the deviceinto an intramedullary channel in a bone, the liquid material is delivered through the lumenand exit portsinto the intramedullary channel. The fluid delivery devicecan be configured to be coupled to the sidearmof the fittingand deliver a liquid material from the material sourcethrough the inner passageof the fittinginto the lumenof the elongate body. In some embodiments, the fluid delivery systemcan include a capthat is configured to be coupled to the proximal end of the fittingto seal the proximal opening of the inner passage. In embodiments having no sidearm, the fluid delivery devicemay be connected to the proximal end portionof the fittingin place of the cap.

2 FIG.B 34 40 40 35 22 24 22 42 23 40 40 44 46 24 40 24 46 44 30 40 24 24 44 40 40 24 44 As shown in, in some embodiments the fluid delivery systemcomprises a tube or catheter(hereinafter referred to as catheter) coupled to the fluid delivery deviceand configured for insertion through the fittinginto the lumen. Optionally the fittingmay include a sealin the inner passage, such as an O-ring or other suitable means for providing a fluid seal around tube or catheter. The cathetercan have at least one axial lumen therein extending to a delivery portat its distal end portionthrough which liquid material can be delivered into the lumen. The catheteris slidable within the lumensuch that the distal end portionmay be positioned at a selectable axial location therein. In this way, the delivery portmay be positioned near a selected one or more of the exit portsso that the liquid material may be directed preferentially through such exit port(s). In some embodiments, the catheteris configured to fit snugly but slidably within the lumensuch that liquid material is inhibited from flowing proximally through the lumenfrom the delivery portof the catheter. In other embodiments, the catheterhas a diameter somewhat smaller than the inner diameter of the lumento allow the liquid material to flow proximally, as well as distally and laterally, from the delivery port.

40 40 24 40 24 40 40 The cathetermay be either rigid or flexible, and may have various embodiments including a metal hypotube, a polymeric tube or cannula, a single-or multi-lumen catheter, or other suitable tubular delivery device. The cathetercan be sized and configured for insertion into the lumenand suitable for delivering the relevant liquid material into the intramedullary channel at the desired pressures and flow rates. In some embodiments, highly viscous materials such as bone cement may be delivered, in which case the catheterwill be configured to withstand the higher pressures required to deliver such materials through a channel the size of the lumenover the desired distance in the intramedullary channel. In such embodiments, the wall of the cathetermay be reinforced with a braided material or other suitable reinforcing means. In some embodiments, the catheterhas a diameter of about 6-12 French, and is configured to withstand delivery pressures of up to about 300 psi.

40 24 40 40 40 40 40 24 30 8 The cathetercan optionally include radiopaque markers and/or external visual markings to allow radiographic and/or direct visualization of the catheter when inserted into lumen. Radiopaque dye can also be infused in the material used to construct the catheteror in a coating thereon. Radiopaque markings at the distal end portion and/or along the length of catheterallow the position of the catheterto be radiographically visualized relative to the intramedullary device and/or the surrounding bone. This facilitates placement of the catheterat the desired site of delivery of the liquid material. In some embodiments, the cathetermay be visualized while it is inserted within the lumento position the distal port near a selected one or more exit ports, or in the intramedullary channel distally of the device.

40 24 8 24 8 40 Optionally, the cathetermay have one or more balloons attached near its distal end portion, and an inflation lumen in addition to a liquid delivery lumen. The inflation lumen communicates with the interior of the balloon(s) to enable balloon inflation. Such balloons may be used to occlude a selected location(s) in the lumenof the intramedullary deviceso as to block proximal or distal flow of the liquid material, or to isolate a region of the lumento which liquid material is to be directed. Such a balloon may also be advanced distally of deviceand inflated within the intramedullary channel, e.g., to widen the channel to accommodate bone cement or other materials, or to occlude the intramedullary channel so as to block material from flowing distally. In such cases, cathetermay have an exit port in a sidewall thereof, either distally or proximally of the balloon, which communicates with the liquid delivery lumen therein.

40 8 40 8 In some embodiments, the cathetermay comprise a single or multi-lumen polymer tube sized for insertion in the reamed channel in a bone which is typically created prior to insertion of the intramedullary device. The cathetermay be advanced over a guidewire into the intramedullary channel and used to deliver bone cement, biologics, or other materials inside the intramedullary channel through exit ports on the end or sides of the catheter prior to insertion of the device.

40 40 The cathetermay include one or more balloons at its end or any other location thereon to limit the flow of liquid material to a specific area. Moreover, the cathetercan include radiopaque markers and/or external markings to allow radiographic visualization of the catheter within the bone and navigating to the desired site of delivery of the liquid material.

34 35 8 24 34 35 36 34 40 40 The fluid delivery systemand/or fluid delivery devicecan be configured to deliver a desired liquid material into the deviceand/or directly into the intramedullary channel. In some embodiments, the liquid material may comprise a viscous material such as low viscosity bone cement having a viscosity in the range of about 10-100 cP, or in some cases higher. In order to deliver such material through the lumen, which will typically have an inner diameter in the range of about 2-4 mm, the fluid delivery device can be configured to deliver the liquid material at a pressure of at least about 100 psi, 200 psi, or 300 psi. In some embodiments, the fluid delivery systemand/or fluid delivery devicecomprises a power injector, electrically or pneumatically powered, capable of delivering highly viscous liquid material at these pressures. The material source, and all of the tubing, reservoirs, material containers, etc. associated with the fluid delivery system, as well as the catheter, will be appropriately constructed to withstand these pressures. In some embodiments, the catheterincludes a reinforced wall with, e.g., a braided material, a coil, etc. embedded therein.

34 35 Additionally or alternatively, the fluid delivery systemand/or fluid delivery devicemay be configured to deliver less viscous liquid materials such as biologics or pharmacologic solutions, and may comprise a syringe, a fluid pump, or other suitable delivery means.

3 3 FIGS.A andB 3 3 FIGS.A andB 100 100 100 102 100 100 102 104 106 108 110 112 114 116 104 106 show an intramedullary device(or “device”) configured in accordance with several embodiments of the present technology. The devicecomprises a selectively rigidizable elongate bodyconfigured to follow a curved intramedullary channel in a bone. In several of such embodiments, an intramedullary deviceis configurable in a curved or straight shape. Although shown as being shaped in a single curve in a single plane, the device may be configured to include multiple curves, where one of the curves is in a different plane than at least another one of the curves. The deviceincludes a bodyformed from one or more body beads, one or more spacer beads, one or more transition beads, a proximal housing, a proximal lock, one or more anchor beads, a distal bead (hereinafter “distal end portion”), and flexible members (not shown in). Different combinations and numbers of body and spacer beadsandcan be utilized to create different-length devices from, e.g., 110 millimeters (mm) to 210 mm long. Longer or shorter devices can also be created for bone fixation in longer or shorter intramedullary bone pathways.

104 106 104 108 110 102 110 112 104 116 100 100 114 116 102 116 122 4 7 FIGS.A-B The body beadsare further described below in conjunction with. Other than its length, each spacer beadis similar to a body bead. Each transition beadis configured to couple the proximal portionto the body. The proximal portionincludes a proximal lock, which is a mechanism configured to cause the remaining portion (e.g., the bodyand the distal portion) of the deviceto be flexible while the proximal lock is in an unlocked state, and which is configured to cause the remaining portion of the deviceto be rigid while the proximal lock is in a locked state. The anchor beadis configured to couple the distal portionto the body, and the anchor bead closest to the distal end includes cable receptacles, also called cable bores, configured to receive the ends of the flexible members. The distal portionincludes relatively sharp threadsconfigured to engage bone by being screwable into bone.

3 3 FIGS.A andB 114 110 112 100 100 112 100 100 100 100 The flexible members (not shown in) extend through internal lumens from the anchor beadto, and into, the proximal portion. The flexible members can comprise metal cables, wire, fibers, plastic or other fibers (e.g., carbon fiber). While the proximal lockis in an unlocked state, the flexible members are free to slide relative to one another in an axial dimension (length dimension of the device) and to acquire a respective bend radius while the deviceis in its flexible state and curved. While the proximal lockis in a locked state, the lock prevents the flexible members from sliding relative to one another in an axial dimension, and the flexible members are configured to maintain, rigidly, the devicein a shape (such as a curved shape) that the deviceacquired while it was in its flexible configuration. In some embodiments, the deviceincludes four flexible members, although the devicecan include fewer than, or more than, four cables.

114 120 110 120 3 3 FIGS.A andB 3 FIG.A 3 FIG.A The distal ends of the flexible members can be coupled to a stabilizing bead, end cap, and/or other structure along the length of the device (e.g., by press fitting, welding, etc.) to keep the distal ends of the flexible members from “slipping through” the most-distal anchor bead. In, the distal ends of the flexible members are coupled to a bead. The bead may be made from any suitable material, such as steel or another metal, or from a polymer. Furthermore, although not shown in, the proximal ends of the flexible members (which are, in, hidden from view by a housing of the proximal portion) may also be fitted with a stabilizing bead, end cap, and/or other structure that are the same as, or that are similar to, bead.

3 FIG.B 100 200 100 200 100 100 200 200 40 Referring to, the devicealso includes a delivery channel(also called a guidewire or central opening or through hole) along a longitudinal axis of the device, according to some embodiments. The delivery channelis configured to receive a guidewire (not shown) such that during an implantation procedure, a surgeon can slide the deviceover a guidewire that was previously inserted into an intramedullary channel of a fractured bone. Typically, after the deviceis implanted, the surgeon removes the guidewire from the delivery channel. The delivery channelmay also be configured to receive a liquid material and/or a fluid delivery catheter (such as fluid delivery catheter), as detailed herein.

4 4 FIGS.A andB 3 FIG.B 104 104 201 202 300 500 508 104 100 508 200 100 500 201 508 500 104 100 104 are perspective and top views, respectively, of an example body bead. Each body beadcan include a base, two tabs, one pocket, four holesfor receiving one of the flexible members therethrough, and a central through hole. When the body beadsare assembled in the device, the central through holescan be generally axially aligned so as to collectively form the delivery channel(see) extending through all or most of the length of device. The through holescan be evenly spaced (e.g., approximately 90 degrees apart) around a periphery of the base, and the center through holecan be centered within the base. Other spacings are possible. The through holesare configured to allow free axial movement of the flexible members and beadswith respect to each other while the deviceis unlocked and, therefore, is in a flexible configuration. The body beadcan be made from any suitable material, such as surgical steel, titanium, another metal, or a polymer (e.g., PEEK or others).

202 206 208 202 400 201 400 100 200 202 506 104 500 Each of the tabscan have a “lollipop” shape, with a stem, or neck,and a head. Each of the tabshas a respective chamfered surfacethat begins at a height spaced above the top surface of the base. The chamfered surfacefacilitates bending of the devicewhile a guidewire is present within the delivery channel. Each tabhas curved sidewalls, which allow rotation and other movement of the beadrelative to the other beads with reduced or no interference with the flexible members that extend through the through holes.

300 202 302 304 201 104 300 202 104 100 The pocket, like the tabs, can have a lollipop shape, with a stem, or neck,and a head, and extends, with its full cross-sectional dimensions, all the way through the baseof the bead. The pocketcan be configured to receive the tabsof another beadin a manner that allows the two beads to rotate relative to one another so that the devicecan bend and curve.

5 5 FIGS.A andB 900 100 40 200 46 40 200 40 200 104 100 200 100 100 100 100 illustrate a segmentof the devicelocked in a curved shape and positioned within an intramedullary channel of a bone (not shown). A flexible fluid delivery catheter (e.g., catheter, etc.) is shown inserted into the delivery channel. The distal end portionof the cathetermay be positioned at a selected axial location within the delivery channelusing radiographic visualization. Liquid material, such as bone cement or other material, may then be delivered through the catheterinto the delivery channel. Gaps G between adjacent body beadscan provide exit ports along the length of devicethrough which the liquid material flows from the delivery channelinto the intramedullary channel. Advantageously, bone cement may be delivered in this fashion so that it hardens both within and around deviceas well as in gaps G, thereby anchoring the devicein the intramedullary channel, assisting in locking the devicein its curved shape, and adding greater stiffness to the deviceto immobilize the fractured bone.

6 6 FIGS.A andB 5 5 FIGS.A andB 104 100 100 104 509 511 508 509 104 511 500 500 500 illustrate another example of a body beadfor use with the device. As shown, in some embodiments of the device, one, some, or all of the body beadscan include at least one exit portin a sidewall thereof which communicates via a transverse channelwith central through hole. In some embodiments, multiple exit portsare disposed at spaced apart locations around the circumference of bead, for example 180 degrees apart as shown in. Other numbers of channels and ports and spacings are possible. Channel locations can be selected such that transverse channelsdo not intersect with the through holes. However, in some embodiments the transverse channels may communicate with the through holesto allow liquid material such as bone cement to be delivered into the through holes, thereby assisting in locking the cables in position when the device is in its desired implanted shape.

7 7 FIGS.A andB 7 7 FIGS.A andB 900 100 100 40 200 40 200 44 104 509 40 200 511 509 40 508 44 40 508 illustrate a segmentof the devicehaving at least a few beads having exit ports. In, the deviceis locked in a curved shape and positioned within an intramedullary channel of a bone (not shown). A flexible fluid delivery catheter (e.g., catheter, etc.) is shown inserted into the delivery channel. The cathetermay be inserted and advanced to a desired axial position within the delivery channel, such that the delivery portis disposed within a selected bead, or near a selected exit port. Liquid material such as bone cement or biologic or pharmacologic materials may then be delivered via the catheterinto the delivery channel, from which the liquid material flows through the transverse channelsand exit portsinto the intramedullary channel. In some embodiments, catheteris configured to fit snugly but slidably within through holesso that liquid material is inhibited from flowing proximally from the delivery port. In other embodiments, catheteris of smaller diameter than through holeto allow flow of material both distally and proximally.

100 104 508 508 104 511 509 509 104 100 104 100 104 100 40 509 200 100 200 509 In some embodiments, the devicemay include a tubular sleeve or series of tubular sleeves (not shown) extending between two or more adjacent beadsand interconnecting the central through holestherein. The tubular sleeve or sleeves may pass through, or partially through, central through holesand may be fixed to beadstherein, so as not to block transverse channelsor exit ports. Such tubular sleeves may be composed of a flexible polymer to allow relative movement of adjacent beads and will be configured to inhibit fluid leakage through gaps G between adjacent beads. In this way, the liquid material may be directed specifically to the exit portswithout flowing through gaps G. In some embodiments, the tubular sleeves may extend between a selected plurality of beadsin a more proximal region of the device, while no sleeves extend between beadsin a distal region of device. In other cases, tubular sleeves may extend between all of the adjacent beadson the device. In certain embodiments, the cathetermay be configured to pass slidably within the tubular sleeves to deliver liquid material to one or more selected exit ports. In some embodiments, the delivery channelmay be connected directly to a fluid delivery apparatus at the proximal end portion of the deviceto allow liquid material to be delivered directly through delivery channeland the tubular sleeve(s) to the exit ports.

8 FIG. 1 2 FIGS.A-B 1 2 FIGS.A-B 110 100 110 3204 3208 3201 3208 3200 110 3201 200 104 3201 3201 3200 3201 3201 200 100 40 3201 200 3203 40 3200 illustrates an example of several embodiments of a proximal portionof the device. The proximal portionincludes a housing, a locking mechanismat its proximal end portion, and a central passageextending axially through the locking mechanismto a distal end portion of the housing. At the distal end portion of the housing, the central passagecommunicates with the delivery channelin the beads. The central passagemay be configured for coupling to a fluid delivery system and/or device as described above in connection with. For example, the central passagemay include threads, or the housingmay include a luer lock arrangement on its proximal end, to allow a fitting to be coupled to the proximal housing in fluid communication with central passage. The fitting may allow direct connection of a tube or conduit from a fluid delivery system and material source, as described in connection with, allowing delivery of liquid material directly into central passageand thus to delivery channelof the device. Alternatively, a delivery catheter, as described above, may be slidably inserted into central passageand advanced into delivery channelof the device. A fluid delivery device, such as a syringe, may be connected to catheterfor delivery of liquid material thereto. Additional details regarding the proximal portioncan be found in U.S. patent application Ser. No. 17/286,389, filed Apr. 16, 2021, Publication No. US2021/0386465, which is incorporated herein by reference in its entirety.

9 9 FIGS.A andB 3400 100 3400 100 3400 3204 3200 3208 3402 3400 3300 3204 3404 3400 3402 3208 3402 3210 3208 3402 3210 3400 3200 3405 3400 3208 illustrate an inserter toolfor use with the deviceof the present technology. The inserter toolis configured to insert, extract, rotate, lock, and unlock the device. The inserter toolattaches to a housingof proximal portionand securely holds onto the device and allows the locking mechanismto be actuated (e.g. rotated) in order to lock the device into a rigid configuration. Tangsof the toolare placed into open slotsof the proximal housing. An outer tubeof the toolis movable distally down the length of the tool to press the tangsinward toward the locking mechanismof the device. The ends of the tangsare captured in a grooveof the proximal lock. When pressed inward enough, the tangsare locked into the grooveand, therefore, the toolis securely attached to the device. A lock activatoris rotatable on inserter toolto actuate the locking mechanism, locking the device in a rigid state.

3400 40 200 100 3400 3411 3404 3400 3411 3201 3204 40 3411 3201 200 9 FIG.A 9 FIG.B Inserter toolmay be configured to receive and guide a delivery catheterinto the delivery channelof devicewhile the inserter is coupled to the device. Advantageously, this permits the surgeon to insert the device in the intramedullary channel, actuate the locking mechanism, then deliver liquid material such as bone cement through the device, without removal of the inserter tool from the device, and without having to manipulate the catheter through the skin incision and into the proximal end of the device manually. As shown in, inserter toolmay include a central bore or passageextending axially through lock activatorand through the entire length of inserter tool. As may be seen in, the central borealigns with central passagein proximal housingof the device, allowing catheterto be advanced from central boreinto the central passage, and from there into delivery channelof the device.

3400 3404 3411 3201 3405 3411 3411 200 In other embodiments, inserter toolis configured to be coupled to proximal housingin a manner which creates a fluid tight interconnection between central boreand central passage. In such embodiments, the proximal end of lock actuatoris configured for fluid connection of central boreto a fluid delivery apparatus, and may include a luer lock or other suitable fitting. In this way, liquid material may be delivered from the fluid delivery apparatus directly into central bore, from which it passes into delivery channelof the device, without the need for insertion of a separate catheter.

Additional details regarding the inserter tool can be found in U.S. application Ser. No. 17/286,389, filed Apr. 16, 2021, Publication No. US2021/0386465, which is incorporated herein by reference in its entirety.

10 FIG. 4000 4000 4002 4000 4004 4002 4006 illustrates an intramedullary treatment systemaccording to several embodiments of the present technology. Systemincludes an implantable intramedullary device, which may comprise any of the intramedullary devices described in this application. Systemfurther includes a fluid delivery apparatus, which may comprise one or more of a syringe, power injector, pump, fluid delivery catheter, or hypotube as described elsewhere herein, and such tubing and fittings as are needed for fluid connection to intramedullary device. A liquid material, or one or more components thereof in liquid or dry form, may be provided in one or more material containers. The liquid material may comprise, as described above, bone cement, a biologic, a pharmacologic solution, or other material useful in conjunction with the implantable intramedullary devices of the invention.

4000 4008 4002 4008 4002 4000 4010 10 FIG. 9 9 FIGS.A-B Optionally, the systemmay further include a guidewirefor use with flexible embodiments of intramedullary devicefor guidance into curved intramedullary channels. Alternatively or additionally, for embodiments in which fluid delivery apparatus comprises a flexible delivery catheter, guidewiremay be provided for use with such a delivery catheter for guidance into an intramedullary channel prior to insertion of the intramedullary device. In some cases, the same guidewire may be used both for guiding the delivery catheter and, following liquid material delivery and removal of the catheter, for guiding the intramedullary device in the intramedullary channel. Further, systemmay include an inserter tool (not shown in), as described above in connection with, which may, in some embodiments, be a single-use disposable. Optionally, a portion or all of these system components may be packaged together in a sterilized packagein the form of a kit, or may be otherwise supplied to the user together as companion products.

Each of U.S. Pat. No. 9,839,435, issued Dec. 12, 2017, U.S. Pat. No. 9,498,264, issued Nov. 22, 2016, U.S. Pat. No. 10,307,188, issued Jun. 4, 2019, U.S. Pat. No. 10,258,394, issued Apr. 16, 2019, U.S. Pat. No. 10,973,559, issued Apr. 13, 2021, PCT Publication No. WO 2020/077457, filed Oct. 17, 2019, and PCT Publication No. WO 2020/081855, filed Oct. 17, 2019, discloses intramedullary fixation devices for use in treating fractures of the pelvis and is incorporated herein by reference in its entirety. Any of the intramedullary devices disclosed in the foregoing references, as well as other intramedullary devices, can be used in conjunction with the methods, systems, and/or devices disclosed in this application.

The devices and methods disclosed herein can be used, for example, in the treatment of one or more of the following conditions and in the corresponding procedures: (1) fractures of the pelvis; (2) conditions of, and procedures for, sacroiliac joint and pubic symphysis; (3) conditions of, and procedures for, the spine, such as spinal fusion, scoliosis, kyphosis, and kyphoscoliosis; (4) fractures of curved bones including proximal femur, proximal humerus, distal humerus, radius, ulna, mandible (lower jaw), calcaneus (heel bone) and ribs; (5) total hip replacement or other joint replacement; (6) revision surgery for replacement of failed artificial joints (e.g. hip or knee joints); (7) treatment of fractures in curved bones caused by osteoporosis or other disease of the bone; and (8) treatment of bone conditions caused by deformities, cancer or other bone diseases. It will be appreciated that the devices and methods disclosed herein can be used to treat additional conditions.

Potential advantages of the intramedullary implants of the present technology for one or more of the aforementioned devices and procedures versus existing techniques and devices include: (1) Stronger holding forces of the flexible intramedullary device in weakened or missing bone. Examples of this are: fixing high impact fractures with missing bone fragments, fixing low impact fractures in osteoporotic or osteopenic bone, fixing bone weakened by tumors or by cancer treatment, or fixing an artificial joint in the case of bone loss due to revision of an artificial joint such as a hip joint. (2) Bonding the intramedullary device to a prosthetic bone implant. The prosthetic implant may be designed to fill gaps within damaged bone. (3) Ability to deliver bone cement, biologics or other materials at one or more predetermined locations along the axial length of the implant. (4) Ability to convert the intramedullary implant into a rigid state with the use of bone cement, biologics or other materials. For example, the injected agent could be used to lock the curvature of the flexible implant. In some examples of these embodiments, the injected agent could fill in gaps or spaces within the flexible section of the implant. After hardening, injected agent would limit motion of the flexible section and convert the implant from a flexible state to a rigid state.

1 10 FIGS.A- Although many of the embodiments are described above with respect to systems, devices, and methods for fixing bones, the technology is applicable to other applications and/or other approaches. Moreover, other embodiments in addition to those described herein are within the scope of the technology. Additionally, several other embodiments of the technology can have different configurations, components, or procedures than those described herein. A person of ordinary skill in the art, therefore, will accordingly understand that the technology can have other embodiments with additional elements, or the technology can have other embodiments without several of the features shown and described above with reference to.

The descriptions of embodiments of the technology are not intended to be exhaustive or to limit the technology to the precise form disclosed above. Where the context permits, singular or plural terms may also include the plural or singular term, respectively. Although specific embodiments of, and examples for, the technology are described above for illustrative purposes, various equivalent modifications are possible within the scope of the technology, as those skilled in the relevant art will recognize. For example, while steps are presented in a given order, alternative embodiments may perform steps in a different order. The various embodiments described herein may also be combined to provide further embodiments.

As used herein, the terms “generally,” “substantially,” “about,” and similar terms are used as terms of approximation and not as terms of degree, and are intended to account for the inherent variations in measured or calculated values that would be recognized by those of ordinary skill in the art.

Moreover, unless the word “or” is expressly limited to mean only a single item exclusive from the other items in reference to a list of two or more items, then the use of “or” in such a list is to be interpreted as including (a) any single item in the list, (b) all of the items in the list, or (c) any combination of the items in the list. Additionally, the term “comprising” is used throughout to mean including at least the recited feature(s) such that any greater number of the same feature and/or additional types of other features are not precluded. It will also be appreciated that specific embodiments have been described herein for purposes of illustration, but that various modifications may be made without deviating from the technology. Further, while advantages associated with certain embodiments of the technology have been described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages to fall within the scope of the technology. Accordingly, the disclosure and associated technology can encompass other embodiments not expressly shown or described herein.